MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-03-25 for DAVINCI SURGICAL SYSTEM 380637-01 N/A manufactured by Intuitive Surgical, Inc.
[184982894]
Based on the information provided, an injury occurred that required medical intervention. According to the surgeon, the patient death was related to a recurrence of cervical cancer. If additional information is received a follow-up mdr will be submitted. No system logs are available for review, since the procedure date is unknown and the system used related to the event cannot be determined. Although there was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred, this complaint was reported due to the following conclusion: it was reported through a journal article that a patient underwent robotic-assisted hysterectomy procedures. During the surgical procedure it was reported that a patient sustained an injury to the left iliac artery that required suturing. There is no allegation that an intuitive device malfunctioned in a way that caused or contributed to the patient death blank mdr fields: follow-up was attempted, but the patient information was either unknown or unavailable. 510k/pma is blank as the system used related to the event cannot be determined. The sections that are not applicable to this product are blank. Implant date is blank because the product is not implantable. The initial reporter section are not available for the site. This report has been generated in response to fda inspectional observations dated 06-mar-2020.
Patient Sequence No: 1, Text Type: N, H10
[184982895]
It was reported through a journal article that a patient underwent robotic-assisted hysterectomy procedures. During the surgical procedure it was reported that a left iliac artery bifurcation injury occurred during the procedure. The injury required suturing to repair. The patient was discharged and allegedly expired an unknown time later due to a recurrence of cervical cancer. There was no allegation of a malfunction of the device, however, it was stated that the patient anatomy may have led to the injury in collaboration with using the da vinci system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2955842-2020-10236 |
| MDR Report Key | 9881661 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2020-03-25 |
| Date of Report | 2018-07-27 |
| Date of Event | 2011-12-05 |
| Date Mfgr Received | 2018-07-27 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVID WANG |
| Manufacturer Street | 3410 CENTRAL EXPRESSWAY |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal | 95051 |
| Manufacturer Phone | 4085232100 |
| Manufacturer G1 | INTUITIVE SURGICAL, INC |
| Manufacturer Street | 3410 CENTRAL EXPRESSWAY |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95051 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAVINCI SURGICAL SYSTEM |
| Generic Name | PATIENT SIDE CART |
| Product Code | NAY |
| Date Received | 2020-03-25 |
| Model Number | 380637-01 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTUITIVE SURGICAL, INC |
| Manufacturer Address | 3410 CENTRAL EXPRESSWAY SANTA CLARA CA 95051 US 95051 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-25 |